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临床试验/NCT01560299
NCT01560299已完成不适用

Evaluation of Optimal Time of Methimazole Discontinuation Before Radio-iodine Therapy in Hyperthyroid Grave's Patients

Mashhad University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
thyroid function tests over one year after radioiodine therapy

研究概览

简要总结

Iodine therapy is the best treatment for graves disease.Most patients receive methimozale prior to radio-iodine treatment. This may decrease treatment response to iodine therapy.

Some physicians advice to discontinue methimazole 3 days before radioiodine therapy and others prefer longer off - methimazole period which bothers most patients. This study aimed to evaluate optimum time for methimazole discontinuation in graves disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-65
  • graves disease(TSH<0.1 &increased FT4 & positive TSI
  • one or more bartlena criteria for radio-iodine therapy
  • 24 hour RAIU>25%
  • euthyroidism after methimazole treatment

排除标准

  • pregnancy or lactation
  • moderate or severe graves ophthalmopathy
  • CHF or coronary heart disease
  • palpable thyroid nodule
  • lithium or amiodarone or lugol or ipodate treatment
  • recent imaging with contrast agent
  • very large goiter(more than 150 gram)

研究组 & 干预措施

group one

Active Comparator

This group will be advised to discontinue methimazole 24-48 hour before iodine therapy

干预措施: Methimazole (Drug)

group two

Active Comparator

methimazole stopped 48-72 hour before radioiodine therapy

干预措施: Methimazole (Drug)

group three

Active Comparator

干预措施: Methimazole (Drug)

结局指标

主要结局

thyroid function tests over one year after radioiodine therapy

时间窗: months 1 , 3 ,6,9,12

thyroid function test may change over one year . In order to consider the patients as cured ,thyroid function tests should reveal hypothyroidism or euthyroidism . In order to rule out temporary hypothyroidism the tests should be repeated after 6 months of radioiodine therapy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

S.R.ZAKAVI

associate professor

Mashhad University of Medical Sciences

研究点 (1)

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